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510(k) Data Aggregation

    K Number
    K140560
    Device Name
    ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Date Cleared
    2014-04-22

    (48 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K130653,K110385,K121600,K070887,K051002,K131663,K112056
    Why did this record match?
    Reference Devices :

    K130653,K110385,K121600,K070887,K051002,K131663,K112056

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

    Device Description

    The Echelon Flex Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in two shaft lengths: regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a battery pack that must be installed prior to use. The Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) are designed for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Flex Powered and Echelon Flex Powered Plus) in a 60mm configuration.

    AI/ML Overview

    This document describes a 510(k) submission for surgical staplers and reloads, focusing on substantial equivalence to predicate devices. It does not contain information about the acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets such criteria.

    The submitted text focuses on the device's mechanical and electrical performance, biocompatibility, and electromagnetic compatibility. It is a traditional medical device submission, not specifically related to software as a medical device (SaMD) or AI/ML.

    Therefore, I cannot provide the requested information, such as acceptance criteria table, sample sizes for test/training sets, expert qualifications, or details about MRMC studies.

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